FDA.reportPublic FDA data

D-SPECT® L

Primary DI
07290108670042
Brand
D-SPECT® L
Company
SPECTRUM DYNAMICS MEDICAL, INC
Model
001
Catalog number
8010020-01
Device description
Single-photon emission computed tomography system
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KPSSystem, Tomography, Computed, Emission
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110507000CARDIAC SCANNER AND PROCESSING SYSTEMSpectrum Dynamics (Israel) , Ltd.2011-07-13KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290108670042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290108670042072901086700427290108670042

GMDN Terms#

Term, Definition table
TermDefinition
SPECT system, annular detector arrayAn assembly of devices comprising a diagnostic, stationary, single photon emission computed tomography (SPECT) system designed exclusively for use in tomographic imaging applications. It detects, records, quantifies and analyses radionuclide emissions produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. The gantry position is fixed and the imaging table/chair moves/rotates under computer or manual control. Its imaging capabilities include static and dynamic imaging applications and three-dimensional (3-D) digital image reconstruction/display at any angle including axial, coronal and sagittal planes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078864620
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290108670523D-SPECT RefurbishedD-SPECT 0028010517-012026-02-09
07290108670097D-SPECT Refurbished0028010517-012025-06-30
07290108670172VERITON CTVERITON CT 4168010421-012023-06-01
07290108670189VERITON CTVERITON CT 4648010422-012023-06-01
07290108670202VERITON NM3008010426-012023-06-01
07290108670219VERITON CTVERITON CT 3648010420-012023-06-01
07290108670226VERITON CTVERITON CT 3168010419-012023-06-01
07290108670240VERITON NM4008010427-012023-06-01
07290108670233TruSPECT STANDALONE PROCESSING STATION8010290-012022-12-26
07290108670080D-SPECT ® processing and Reviewing WorkstationStand Alone8010113-012017-10-25
07290108670004D-SPECT®0038010029-012016-09-22
07290108670011D-SPECT®0048010029-012016-09-22
07290108670028D-SPECT®0038010018-012016-09-22
07290108670035D-SPECT®0048010018-012016-09-22
07290108670059D-SPECT® L0018010032-012016-09-22
07290108670158D-SPECT RefurbishedD-SPECT 0048010013-012020-08-26
07290108670141D-SPECT VISTA0028010267-012020-06-28
00729018670158D-SPECT RefurbishedD-SPECT 0048010013-012020-08-26
07290108670134D-SPECT VISTA 0028010266-012020-06-28
00729018670141D-SPECT VISTA0028010267-012020-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713390ROSA® ShoulderOrthosoft IncLLZ2026-10-15
B037FFSMD0Synapse MobilityResolutionMD Inc.LLZ2026-10-15
B037NLIVD0Nicolab Image ViewerResolutionMD Inc.LLZ2026-10-15
B037RESMDD0ResolutionMDResolutionMD Inc.LLZ2026-10-15
B133NEUROQ412610120NeuroQSYNTERMED INCORPORATEDKPS2026-10-15
00860013868918MICSI-PETMicroStructure Imaging, Inc.KPS2026-10-14
00860013868918MICSI-PETMicroStructure Imaging, Inc.LLZ2026-10-14
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
05745000308323Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-01-30
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
03663999000375spineEOSEOS IMAGINGLLZ2025-08-01
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28